MAUDE Adverse Event Report: PARAGON 28, INC JAWS NITINOL STAPLE SYSTEM; STRAIGHT STAPLE ASSEMBLY, INSERTER

Model Number P71-018-1818-S

Device Problem Failure to Eject (4010)

Patient Problem Perforation (2001)

Event Date 11/23/2021

Event Type  Injury  

Manufacturer Narrative

Report 2 (staple inserter) of 2.

Event Description

Difficulty with the jaws inserter releasing the staple.

• Brand Name: JAWS NITINOL STAPLE SYSTEM
• Type of Device: STRAIGHT STAPLE ASSEMBLY, INSERTER
• Manufacturer (Section D): PARAGON 28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: jenny conger ; 14445 grasslands dr; englewood, CO 80112 ; 7203721212
• MDR Report Key: 13043765
• MDR Text Key: 282500525
• Report Number: 3008650117-2021-00141
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: P71-018-1818-S
• Device Catalogue Number: P71-018-1818-S
• Device Lot Number: 26031762104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR